COMUNICATO - Variazione di tipo II all'autorizzazione, secondo procedura nazionale, del medicinale per uso umano «Normison». (13A07059)
Estratto determinazione V &
A n. 1358 del 31 luglio 2013 Titolare A.I.C.: Meda Pharma S.P.A. con sede legale e domicilio fiscale in Viale Brenta, 18, 20139 - Milano (codice fiscale 00846530152). Medicinale: NORMISON. Variazione A.I.C.: B.II.d.1.a Modifica dei parametri di specifica e/o dei limiti del prodotto finito Rafforzamento dei limiti delle specifiche B.II.d.1.d Modifica dei parametri di specifica e/o dei limiti del prodotto finito Soppressione di un parametro di specifica non significativo A.5.b Modifica del nome e/o dell'indirizzo del fabbricante del prodotto finito, compresi i siti di controllo della qualita' Tutti gli altri A.7 Soppressione dei siti di fabbricazione [anche per una sostanza attiva, un prodotto intermedio o finito, un sito di imballaggio, un fabbricante responsabile del rilascio dei lotti,un sito in cui si svolge il controllo dei lotti o un fornitore di materia prima, di un reattivo o di un eccipiente B.II.d.1.z Modifica dei parametri di specifica e/o dei limiti del prodotto finito: altra variazione L'autorizzazione all'immissione in commercio e' modificata come di seguito indicata: E' autorizzata la modifica relativa all'eliminazione di un secondo sito di produzione di capsule in bulk, il cambio di nome e indirizzo di un sito di confezionamento secondario, la modifica dei parametri di specifica del prodotto finito, limitatamente a quanto di seguito riportato: A.7 Soppressione dei siti di fabbricazione [anche per una sostanza attiva, un prodotto intermedio o finito, un sito di imballaggio, un fabbricante responsabile del rilascio dei...
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